Status:
RECRUITING
Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma
Lead Sponsor:
Susan E. Bates
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combi...
Detailed Description
The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the c...
Eligibility Criteria
Inclusion
- Pancreatic Ductal Adenocarcinoma
- Plan for neoadjuvant chemotherapy
- Available diagnostic tissue adequate for biomarker analysis
- Ability to tolerate PO meds and comply with study procedures
Exclusion
- Metastatic disease
- Evidence of GI obstruction
- Baseline bradycardia (HR\<55) or hypotension (systolic blood pressure\<90)
- Use of acetylcholinesterase inhibitors
- Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05241249
Start Date
February 1 2022
End Date
January 1 2026
Last Update
June 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center
New York, New York, United States, 10032